FDA Orange Book

Is there a generic for Nevanac?

Nevanac contains nepafenac. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Nevanac (nepafenac). The Orange Book shows its last listed patent expires January 31, 2027.

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Nevanac products in the Orange Book

Nevanac products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension/drops, ophthalmic0.1%Marketed (Rx)None0None

NDA 021862, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Nevanac patents

Patents listed for Nevanac
PatentExpiresCoversUse codeNDA
7834059January 31, 2027Method of useU-1095021862

Nevanac NDC codes

Questions

Is there a generic for Nevanac?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Nevanac (nepafenac). The Orange Book shows its last listed patent expires January 31, 2027.

What is the generic name for Nevanac?

The active ingredient in Nevanac is nepafenac, per the FDA Orange Book.

When does the Nevanac patent expire?

The last patent listed for Nevanac in the Orange Book expires January 31, 2027. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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